Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder - Full Text View

Purpose

The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).

Condition	Intervention	Phase
Major Depressive Disorder	Drug: RX-10100	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Rexahn Pharmaceuticals, Inc.:

Primary Outcome Measures:

Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	December 2010
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RX-10100 high dose RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks	Drug: RX-10100 Extended-release tablet, taken twice daily for 8 weeks Other Name: Serdaxin®
Experimental: RX-10100 low dose RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks	Drug: RX-10100 Extended-release tablet, taken twice daily for 8 weeks Other Name: Serdaxin®
Placebo Comparator: Placebo Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks	Drug: RX-10100 Extended-release tablet, taken twice daily for 8 weeks Other Name: Serdaxin®

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS).

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not willing to practice a reliable method of birth control
Depressive episode duration of less than 1 month
Lifetime history of any psychotic disorders
Anxiety disorders
Significant suicidality
Clinically significant medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273376

Hide Study Locations

Locations

United States, California
Rexahn Investigative Site
Cerritos, California, United States, 90703
Rexahn Investigative Site
Escondido, California, United States, 92025
Rexahn Investigative Site
Los Angeles, California, United States, 90024
Rexahn Investigative Site
National City, California, United States, 91950
Rexahn Investigative Site
Oceanside, California, United States, 92056
Rexahn Investigative Site
Orange, California, United States, 92868
Rexahn Investigative Site
San Diego, California, United States, 92123
United States, Colorado
Rexahn Investigative Site
Denver, Colorado, United States, 82039
United States, Florida
Rexahn Investigative Site
Brooksville, Florida, United States, 34601
Rexahn Investigative Site
Gainesville, Florida, United States, 32607
Rexahn Investigative Site
Jacksonville, Florida, United States, 32216
Rexahn Investigative Site
Miami Beach, Florida, United States, 33139
Rexahn Investigative Site
Orlando, Florida, United States, 32806
Rexahn Investigative Site
St. Petersburg, Florida, United States, 33709
Rexahn Investigative Site
Tampa, Florida, United States, 33606
United States, Georgia
Rexahn Investigative Site -2
Atlanta, Georgia, United States, 30328
Rexahn Investigative Site
Atlanta, Georgia, United States, 30328
United States, Illinois
Rexahn Investigative Site
Oak Brook, Illinois, United States, 60523
Rexahn Investigative Site
Vernon Hills, Illinois, United States, 60061
United States, Kentucky
Rexahn Investigative Site
Owensboro, Kentucky, United States, 42301
United States, Michigan
Rexahn Investigative Site
Novi, Michigan, United States, 48377
United States, Nevada
Rexahn Investigative Site
Las Vegas, Nevada, United States, 89146
United States, New Jersey
Rexahn Investigative site
Cherry Hill, New Jersey, United States, 08002
United States, New Mexico
Rexahn Investigative Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Rexahn Investigative Site
Fresh Meadows, New York, United States, 11366
Rexahn Investigative Site
New York City, New York, United States, 10021
United States, Ohio
Rexahn Investigative Site
Cincinnati, Ohio, United States, 45227
Rexahn Investigative site
Garfield Heights, Ohio, United States, 44125
United States, Oklahoma
Rexahn Investigative Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Rexahn Investigative site
Allentown, Pennsylvania, United States, 18103
Rexahn Investigative Site
Media, Pennsylvania, United States, 19063
Rexahn Investigative Site
Scranton, Pennsylvania, United States, 18503
United States, South Carolina
Rexahn Investigative Site
Anderson, South Carolina, United States, 29621
United States, Tennessee
Rexahn Investigative Site
Memphis, Tennessee, United States, 38119
United States, Texas
Rexahn Investigative Site
Austin, Texas, United States, 78756
Rexahn Investigative site
Dallas, Texas, United States, 75231
Rexahn Investigative Site
Dallas, Texas, United States, 75390
Rexahn Investigative Sites
Lake Jackson, Texas, United States, 77566
Rexahn Investigative Site
San Antonio, Texas, United States, 78229
Rexahn Investigative Site
The Woodlands, Texas, United States, 77381
United States, Utah
Rexahn Investigative Site
Orem, Utah, United States, 84058
United States, Virginia
Rexahn Investigative Site
Richmond, Virginia, United States, 23284
United States, Washington
Rexahn Investigative Site (2)
Bellevue, Washington, United States, 98007
Rexahn Investigative Site
Bellevue, Washington, United States, 98007

Sponsors and Collaborators

Rexahn Pharmaceuticals, Inc.

Investigators

Study Director:

Christine Peterson, Ph.D

Rexahn Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01273376 History of Changes
Other Study ID Numbers:	2010MDD01
Study First Received:	January 6, 2011
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Rexahn Pharmaceuticals, Inc.:

MDD
Depression
Major Depression

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 22, 2013

Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder (MDD)